DeviceClearance

K990020

Substantially Equivalent

TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

Applicant
Te ME NA S.A.R.L.
Product code
FMF
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Clearwater, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF
Death
15
Injury
2,263
Malfunction
29,722
Other
17
Total
32,017

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.